USFDAMay 1, 2026, 09:17 AM
AZN: FDA ODAC Recommends Truqap for PTEN-Deficient Prostate Cancer
AI Summary
AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) received a favorable recommendation from the US FDA's Oncologic Drugs Advisory Committee (ODAC) for PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). The Committee voted 7 to 1, with 1 abstaining, recognizing a favorable benefit-risk profile based on the CAPItello-281 Phase III trial. This marks the first and only targeted treatment combination to demonstrate benefit in this specific subtype of prostate cancer, addressing a significant unmet patient need. The FDA will consider this feedback as it reviews the supplemental New Drug Application.
Key Highlights
- ODAC voted 7 to 1 (with 1 abstaining) for Truqap's favorable benefit-risk profile in PTEN-deficient mHSPC.
- CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death.
- Median radiographic progression-free survival (rPFS) was 33.2 months for Truqap combination vs 25.7 months for comparator.
- Hazard ratio (HR) for rPFS was 0.81 (95% CI 0.66-0.98; p=0.034).
- Time to castration resistance was prolonged to 29.5 months vs 22.0 months (HR 0.77).
- Grade 3 or higher adverse events occurred in 67% of Truqap combination patients vs 40.4% in comparator.
- Approximately one in four patients with metastatic hormone-sensitive prostate cancer (mHSPC) have PTEN-deficient tumors.